Dec 14, 2020

First COVID-19 vaccine doses arrive at sites across the U.S.

Posted Dec 14, 2020 8:00 AM
Team members used FecEx integrated air and ground network to ensure the vaccines are delivered safely to destinations across the U.S.-photo courtesy FedEx
Team members used FecEx integrated air and ground network to ensure the vaccines are delivered safely to destinations across the U.S.-photo courtesy FedEx

PORTAGE, Michigan (AP) — The first of many freezer-packed COVID-19 vaccine vials made their way to distribution sites across the United States on Sunday, as the nation’s pandemic deaths approached the horrifying new milestone of 300,000.

The rollout of the Pfizer vaccine, the first to be approved by the Food and Drug Administration, ushers in the biggest vaccination effort in U.S. history — one that health officials hope the American public will embrace, even as some have voiced initial skepticism or worry. Shots are expected to be given to health care workers and nursing home residents beginning Monday.

Quick transport is key for the vaccine, especially since this one must be stored at extremely low temperatures — about 94 degrees below zero. Early Sunday, workers at Pfizer — dressed in fluorescent yellow clothing, hard hats and gloves — wasted no time as they packed vials into boxes. They scanned the packages and then placed them into freezer cases with dry ice. The vaccines were then taken from Pfizer’s Portage, Michigan, facility to Gerald R. Ford International Airport in Grand Rapids, where the first cargo plane took off amid what airport officials called a “jubilant” mood.

“This is a historic day,” said Richard W. Smith, who oversees operations in the Americas for FedEx Express, which is delivering 630-some packages of vaccine to distribution sites across the country. United Parcel Service also is transporting a share of the vaccine.

Helping with the transport of the vaccine has special meaning to Bruce Smith, a FedEx package handler at the Grand Rapids airport, whose older sister, Queen, died after she contracted the coronavirus in May. She was hospitalized in Georgia one day after he saw her on a video chat, and they never spoke again.

“I think she would be ecstatic to know that something that has ravaged our family — that a family member is going to be part of such a big project,” said Smith, 58, whose nephew, Queen’s son, also got sick and is still undergoing therapy for stroke-like symptoms. “It is very, very important.”

Tracked with GPS-enabled sensors, the initial shipments were expected to contain about 3 million doses, with many more to come. Federal officials say the first shipments of Pfizer’s vaccine will be staggered, arriving in 145 distribution centers Monday, with another 425 sites getting shipments Tuesday, and the remaining 66 on Wednesday. Doses of the vaccine, co-developed by German partner BioNTech, are given out based on each state’s adult population. Then the states decide where they go first.

In California, where health care workers will be among the first to be vaccinated, state health officials are prioritizing hospitals that have adequate storage capacity, serve high-risk populations and have the ability to vaccinate people quickly.

Initial surveys have found that even some health care workers don’t want to be first in line. Dr. Graham Snyder, who’s led the vaccine task force at Pennsylvania health care giant UPMC, estimates that about half of its employees are willing to get the vaccine as soon as it’s offered.

But many health officials expect enthusiasm to grow.

“There’s that thought that maybe they don’t have to be so afraid to come to work if they can be vaccinated and be immune,” said Dr. Sandra Kemmerly, medical director of hospital quality at the 40-hospital Oschner Health System in Louisiana and Mississippi. Employees approved for the first round are getting texts and emails directing them to schedule their initial injection, she said. Enough vaccine is being saved so that each person who gets the first dose of vaccine can get a second required shot a few weeks later.

Senior U.S. government officials, including some White House officials who work in close proximity to President Donald Trump and Vice President Mike Pence, are among those who will be offered coronavirus vaccines as soon as this week, two people familiar with the matter confirmed.

A survey from The Associated Press-NORC Center for Public Affairs Research found that about half of Americans want to get the vaccine as soon as possible. Another quarter aren’t sure, while the remaining quarter say they aren’t interested. Some simply oppose vaccines in general. Others are concerned that the vaccines have been rushed and want to see how the rollout goes.

Dr. Stephen Hahn, commissioner of the FDA, which approved the Pfizer vaccine Friday, has repeatedly insisted that the agency’s decision was based on science, not politics, despite a White House threat to fire him if the vaccine wasn’t approved before Saturday.

Speaking to Fox News Sunday, Dr. Moncef Slaoui, chief science adviser to Operation Warp Speed, a U.S. effort to get vaccines developed quickly, also said he is “very concerned” about the skepticism about the vaccine in some circles.

“Unfortunately ... there’s been a confusion between how thorough and scientific and factual the work that has been done is, and the perception that people are thinking that we cut corners ...,” Slaoui said. “I can guarantee you that no such things have happened, that we follow the science.”

He called the development of vaccines from several pharmaceutical companies, including Moderna and AstraZeneca, “a remarkable achievement of science, academia, the industry ecosystem and the U.S. government, working together.”

While the vaccine was determined to be safe, regulators in the U.K. are investigating several severe allergic reactions. The FDA’s instructions tell providers not to give it to those with a known history of severe allergic reactions to any of its ingredients.

The Moderna vaccine will be reviewed by an expert panel Thursday and soon afterward could be allowed for public use.

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Pfizer-BioNTech COVID-19 vaccines will originate from storage sites in Michigan and Wisconsin. The vaccines will be transported by FedEx Express using its FedEx Priority Overnight® service and  and to UPS Worldport facilities in Louisville, where they will be expedited Next Day Air to select destinations, including hospitals, clinics and other medical facilities, to inoculate healthcare workers. Photo courtesy UPS
Pfizer-BioNTech COVID-19 vaccines will originate from storage sites in Michigan and Wisconsin. The vaccines will be transported by FedEx Express using its FedEx Priority Overnight® service and  and to UPS Worldport facilities in Louisville, where they will be expedited Next Day Air to select destinations, including hospitals, clinics and other medical facilities, to inoculate healthcare workers. Photo courtesy UPS

KALAMAZOO, Michigan (AP) — The first shipments of a COVID-19 vaccine for widespread use in the United States headed Sunday from Michigan to distribution centers across the country, with the first shots expected to be given in the coming week to health care workers and at nursing homes.

Shipments of the Pfizer vaccine will set in motion the biggest vaccination effort in American history at a critical juncture of the pandemic that has killed 1.6 million and sickened 71 million worldwide.

Initially, about 3 million doses were expected to be sent out, and the priority is health care workers and nursing home residents as infections, hospitalizations and deaths soar in the U.S. With numbers likely to get worse over the holidays, the vaccine is offering a bright spot in the fight against the pandemic that’s killed nearly 300,000 Americans.

Federal officials say the first shipments of Pfizer’s vaccine will be staggered, arriving in 145 distribution centers Monday, with an additional 425 sites getting shipments Tuesday, and the remaining 66 on Wednesday. The vaccine, co-developed by German partner BioNTech, is being doled out based on each state’s adult population.

Pennsylvania health care giant UPMC has chosen staff who are critical to operating its facilities as among those getting the first round of vaccinations, said Dr. Graham Snyder, who led the center’s vaccine task force.

“It’s very exciting. I will be thrilled, that moment when we administer our first dose,” Snyder said Saturday. “That will clearly be a watershed moment for us.”

Snyder said the UPMC system estimates that half its employees are willing to get the vaccine as soon as it’s offered to them.

The vaccine is heading to hospitals and other sites that can store it at extremely low temperatures — about 94 degrees below zero. Pfizer is using containers with dry ice and GPS-enabled sensors to ensure each shipment stays colder than the weather in Antarctica.

Doses should be delivered to all vaccination sites identified by states, such as local pharmacies, within three weeks, federal officials said.

The 40-hospital Oschner Health System in Louisiana and Mississippi expects to receive more than 9,000 doses in the coming days, said Dr. Sandra Kemmerly, medical director of hospital quality.

Employees approved for the first round are getting texts and emails directing them to schedule their initial injection, she said.

“I would say there’s enthusiasm,” Kemmerly said Saturday. “There’s that thought that maybe they don’t have to be so afraid to come to work if they can be vaccinated and be immune.”

The Food and Drug Administration authorized emergency use of the vaccine Friday, saying it is highly protective and presents no major safety issues. While U.S. regulators worked for months to emphasize the rigor and independence of their review, they faced political pressure until the final stages.

Concerns that a shot was rushed out could undermine vaccination efforts in a country where some are skeptical about vaccines — some because of overall opposition to vaccines and others because of the quick timeframe in which the virus vaccines were developed. Even some health care workers have said in surveys that they would forgo at least the first round of shots to see how things go.

The head of the FDA has repeatedly insisted that the agency’s decision was based on science, not politics, despite a White House threat to fire him if the vaccine wasn’t approved before Saturday.

Speaking Sunday to Fox News, Dr. Moncef Slaoui, chief science adviser to Operation Warp Speed, a U.S. effort to get vaccines developed quickly, also said he is “very concerned” about the skepticism about the vaccine in some circles.

“Unfortunately ... there’s been a confusion between how thorough and scientific and factual the work that has been done is, and the perception that people are thinking that we cut corners or anything like that,” Slaoui said. “I can guarantee you that no such things have happened, that we follow the science.”

He called the development of vaccines from several pharmaceutical companies, including Moderna and AstraZeneca, “a remarkable achievement of science, academia, the industry ecosystem and the U.S. government, working together.”

While the vaccine was determined to be safe, regulators in the U.K. are investigating several severe allergic reactions. The FDA’s instructions tell providers not to give it to those with a known history of severe allergic reactions to any of its ingredients.

Another vaccine by Moderna will be reviewed by an expert panel next week and soon afterward could be allowed for public use.

WASHINGTON (AP) — The nation’s first COVID-19 vaccine will begin arriving in states Monday morning, U.S. officials said Saturday, after the government gave the final go-ahead to the shots needed to end an outbreak that has killed nearly 300,000 Americans.

Trucks will roll out Sunday morning as shipping companies UPS and FedEx begin delivering Pfizer’s vaccine to nearly 150 distribution centers across the states, said Army Gen. Gustave Perna of Operation Warp Speed, the Trump administration’s vaccine development program. An additional 425 sites will get shipments Tuesday, and the remaining 66 on Wednesday.

Initially, about 3 million doses were expected to be shipped nationwide. It was unclear exactly who would receive the first shots, though health care workers and nursing home residents were the priority. Perna said health authorities would decide.

A similar number of shots will be held back for those recipients’ second dose, which is needed for full protection from COVID-19.

The announcement Saturday kicks off a massive logistical operation involving the federal and state governments, private companies and health care workers to quickly distribute limited vaccine supplies throughout the U.S. It offers hope in a country grappling with surging COVID-19 infections and deaths, which are overwhelming hospitals and raising fears that things will only get worse as people gather over the holidays.

Perna compared the vaccine distribution effort to D-Day, the U.S.-led military offensive that turned the tide in World War II.

“D-Day was the beginning of the end and that’s where we are today,” Perna said a news conference. But he added that it would take months of work and “diligence, courage and strength to eventually achieve victory.”

MaineHealth, a network of 12 hospitals based in Portland, plans to provide an expected first delivery of nearly 2,000 vaccines to doctors, nurses and others facing risk as they treat COVID-19 patients, said Dr. Dora Mills, chief health improvement officer.

“It’s almost hard for me to talk about without tearing up,” Mills said Saturday. “This vaccine gives us some glimmer of light at the end of the tunnel.”

The first shipments will leave Pfizer’s manufacturing plant in Kalamazoo, Michigan, by truck and then be flown to regional hubs around the country. Medical distributor McKesson and pharmacy chains, including CVS and Rite-Aid, also are involved in the initial rollout and vaccinations at nursing homes and assisted living centers.

In a key distribution challenge, the vaccine, co-developed with BioNTech, must be stored and shipped at ultra-low temperatures — about 94 degrees below zero. Pfizer has developed shipping containers that use dry ice, and GPS-enabled sensors will allow the company to track each shipment and ensure it stays cold.

Distribution sites are mainly large hospitals and other facilities able to meet those ultra-cold storage requirements. Within three weeks, vaccines should be delivered to all vaccination sites identified by states, such as local pharmacies, Perna said.

The vaccine was timed to arrive Monday so health workers could receive the shots and begin giving them, Perna said.

Workers at Mount Sinai Hospital System in New York did a dry run this week to prepare for their shipment. In a clean room, pharmacists practiced making separate doses of a training vaccine and ensuring the freezer was kept at temperatures colder than in Antarctica.

“Not a lot of people have vaccinated for a large pandemic like this,” said Susan Mashni, vice president of pharmacy at Mount Sinai. “So we want to make certain that we get it right. There’s a lot of different moving pieces and parts.”

At a meeting where an expert panel advising the Centers for Disease Control and Prevention on vaccines unanimously endorsed the Pfizer shot, some said local health officials were struggling to ensure the vaccine is distributed fairly and to those most in need and to ease people’s concerns about getting the shot.

But “the funding necessary for state and local health departments to carry out this program has been put in the deep freeze,” said Dr. Jeffrey Duchin, a Seattle physician representing the National Association of County and City Health Officials.

The Food and Drug Administration authorized emergency use of the vaccine late Friday. It capped an unprecedented global race to speed vaccines through testing and review, chopping years off the normal development process.

The FDA found the vaccine highly protective with no major safety issues. U.S. regulators worked for months to emphasize the rigor and independence of their review, but President Donald Trump’s administration pressured the agency until the final announcement. A top White House official even threatened to remove FDA chief Stephen Hahn if a ruling didn’t come before Saturday.

Concerns that a shot was rushed out could undermine vaccination efforts in a country with deeply ingrained skepticism about vaccines.

“Science and data guided the FDA’s decision,” Hahn said Saturday. “We worked quickly because of the urgency of this pandemic, not because of any other external pressure.”

While the vaccine was determined to be safe, regulators in the U.K. are investigating several severe allergic reactions. The FDA’s instructions tell providers not give it to those with a known history of severe allergic reactions to any of its ingredients.

The FDA’s vaccine director, Dr. Peter Marks, said the agency will carefully track any reports of allergic reactions in the U.S.

Next week, the FDA will review a vaccine from Moderna and the National Institutes of Health that appears about as protective as Pfizer’s shot. On Friday, the Trump administration said it had purchased 100 million more doses of that vaccine on top of 100 million it previously ordered.

The announcement came after revelations that the White House opted not to lock in an additional 100 million doses of Pfizer’s vaccine for delivery in the second quarter of 2021. The Trump administration contends the current orders plus those in the pipeline will be enough to accommodate any American who wants to be vaccinated by the end of the second quarter of 2021.

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